Kornimate/medical-research-clean huggingface dataset:
a study to test combination treatments in participants with advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: the purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of nivolumab in combination with ipilimumab or other treatment therapies in participants with advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * inoperable, advanced or metastatic esophageal cancer (ec), gastric cancer (gc) or gastroesophageal junction (gej) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma * eastern cooperative oncology group (ecog) performance status ≤ 1 * at least 1 lesion with measurable disease exclusion criteria: * her2-positive tumor and previously untreated with trastuzumab * suspected, known or progressive central nervous system metastases * other active malignancy requiring concurrent intervention * active, known or suspected autoimmune disease other protocol-defined inclusion/exclusion criteria apply
phase iv trial to collect safety data and sera in healthy children given fluzone vaccine

Conditions: Influenza

Summary: to provide serum to the food and drug administration (fda) for use by fda, the centers for disease control and prevention (cdc), and the world health organization (who) for characterization of circulating influenza strains. observational objectives: to describe the safety of the 2005-2006 pediatric formulation of fluzone vaccine, given in the two-dose schedule in accordance with the package insert, in children aged ≥ 6 months to \< 36 months. to describe the immunogenicity of the 2005-2006 pediatric formulation of fluzone vaccine, administered in a two-dose schedule in accordance with the package insert, in children aged ≥ 6 months to \< 36 months.


Eligibility criteria:
inclusion criteria: * participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday). * participant is considered to be in good health on the basis of reported medical history and limited physical examination. * participant is available for the duration of the study. * parent/legal acceptable representative is willing and able to provide informed consent. * parent/legal acceptable representative is willing and able to meet protocol requirements. * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg. exclusion criteria: * reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. * documented history of influenza infection. * an acute illness with or without fever (temperature ≥ 100.4 °f, rectal) in the 72 hours preceding enrollment in the trial (enrollment may be deferred). * clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). * participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study. * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth. * personal or immediate family history of congenital immune deficiency. * developmental delay, neurologic disorder, or seizure disorder. * chronic medical, congenital, or developmental disorder. * known human immunodeficiency virus (hiv)-positive mother. * prior history of guillain-barré syndrome. * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Keywords: fluzone® influenza virus vaccine
group b strep correlates of protection study

Conditions: Maternal Health; Child Health; Infectious Diseases

Summary: streptococcus agalactiae or group b streptococcus (gbs) is a leading cause of neonatal sepsis in developed and developing countries. the study aims to bolster the evidence base of establishing a sero-correlate of protection against invasive gbs disease in infants. these sero-correlates of protection will be used to study the effectiveness of gbs vaccine against invasive disease.

observational case-control study * a cohort of 15,000 mother-infant dyads will be enrolled at chris hani baragwanath academic hospital (n=10,000) and rahima moosa mother and child hospital(n=5,000) over an 18-24-month period, anticipated to start in the first quarter of 2019. * enrolment into the cohort study will occur at antenatal clinic, during the early stages either of labour or immediately post-delivery. * in parallel, enrolment of gbs cases will occur at the time of diagnosis of invasive gbs disease. these "retrospective cases" will be enrolled at multiple facilities across south africa. * infants will be followed up until 89 days of age to identify cases of suspected sepsis and hospitalizations. determine the infant gbs serotype ia and iii specific capsular serum igg antibody level associated with 80% reduced odds of invasive gbs disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases.

Eligibility criteria:
inclusion criteria: 1. pregnant women attending for antenatal care at one of the participating antenatal-clinics and/or delivering at chbah or rmmch. 2. subjects aged ≥18 years. 3. able to understand and comply with planned study procedures. 4. provides written informed consent. exclusion criteria: 1. refusal to consent to study participation. 2. receipt of any blood products in the past 4 weeks or anticipated during labour.
monitoring of the mitochondrial function of circulating myeloid cells in patients hospitalized in the intensive care unit of dijon university hospital

Conditions: Septicaemia

Summary: severe infections (sepsis) are a common cause of admission to the intensive care unit. they represent a significant health risk for patients in the short and medium term. they are particularly linked to a change in the function of immune cells. in some patients, a state of pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of myeloid cells, is observed. this situation leads to a worsening of the infection, so it should be avoided because it represents a danger for the patient even when they ar receiving antibiotics. at present, these events are still very poorly understood. research is essential to understand how this state of immunosuppression of myeloid cells is established in order to adapt existing treatments or find new ones. laboratory studies on animal models of septicaemia have shown that this state of immunosuppression of myeloid cells is closely linked to a change in the production of energy by myeloid cells (monocytes and macrophages). the functioning of the mitochondria ("energy factory" of the cells) in these cells is impaired. thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe septicaemia. the objective of this study is to verify whether alterations in mitochondrial function in myeloid cells also occur in patients with bacterial infection compared to patients without bacterial infection.


Eligibility criteria:
inclusion criteria: * adult person who has given written consent (or consent obtained from a heath care proxy) hospitalized in an icu with or without sepsis (with or without infection) exclusion criteria: * person not affiliated or not benefiting from national health insurance * person under legal protection (curatorship, guardianship, safeguard of justice) * pregnant, parturient or breastfeeding woman * patient who was hospitalized within 3 months prior to inclusion for sepsis. * patients receiving known treatment for mitochondrial function modulation, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil).
imatinib in adult patients with metastatic ocular melanoma

Conditions: Melanoma

Summary: the scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

further study details as provided by centre oscar lambret

Eligibility criteria:
inclusion criteria: * metastatic ocular melanoma * age \> or = 18 years old * measurable metastases \> or = 10 mm according to recist criteria * ps-who \ 70 percent * normal hepatic function * pnn \> 1500/mm3, platelets \> or = 100 000/mm3 * contraception * informed consent signed exclusion criteria: * patient with two prior lines of systemic treatment (chemotherapy, immunotherapy or association) * other evolutive neoplasic disease * severe hepatic insufficiency * severe renal insufficiency * somatic or psychiatric co-morbidity incompatible with the protocol * leptomeningeal or cerebral metastatic dissemination * pregnant or lactating woman * other antitumoral treatment * patient participating to another clinical trial with an experimental drug * known hypersensitivity to imatinib or one of its excipients * resecable single metastasis

Keywords: ocular, metastatic melanoma
efficacy of tdcs on pain in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: pain is a common symptom experienced by people with ms and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. pain in people with ms has the potential to become chronic, as a consequence of neuronal reorganization. transcranial direct current stimulation (tdcs) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. combining tdcs with rehabilitation treatment may have effect in reducing pain in people with ms. this is a pilot randomized control trial to test the effects of tdcs in ms-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with physical functioning), catastrophizing, emotional functioning and quality of life. furthermore, we will explore the effects on pressure pain threshold and eeg recording. correlations between sample characteristics and pain features will be investigated. considering role of tdcs on neuropsychological functions, selective attention will be assessed.


Eligibility criteria:
inclusion criteria: * chronic pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain, lasting more than 3 months with a minimum score of 3 points on the numeric rating scale (nrs) for pain perception; * lack of ms worsening in the three months just before the intervention period; * cognitive functioning to give informed consent identified by a mini-mental status examination (mmse) score ≥ 24/30. exclusion criteria: * worsening of ms-related conditions or changes in drug therapy or any other confounding factor during the study; * rehabilitation treatments or botulinum toxin injections during the three months preceding the start of the study; * intracranial metal implants that can be stimulated, incorrectly positioned, or overheated by the electric current; * severe cardiopulmonary, renal, and hepatic diseases; * pregnancy.

Keywords: multiple sclerosis pain transcranial direct current stimulation tdcs
a study to assess the long-term safety of qva149

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study is designed to provide long-term safety data for qva149 in patients with moderate to severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * male or female adults aged ≥40 yrs * smoking history of at least 10 pack years * diagnosis of copd (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2008) * post-bronchodilator fev1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator fev1/fvc (forced vital capacity) \<70% exclusion criteria: * patients who have had a respiratory tract infection within 4 weeks prior to visit 1 * patients with concomitant pulmonary disease * patients with a history of asthma * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular co-morbid conditions * patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * patients in the active phase of a supervised pulmonary rehabilitation program * patients contraindicated for inhaled anticholinergic agents and β2 agonists * other protocol-defined inclusion/exclusion criteria may apply

Keywords: qva149 copd combination bronchodilator
safety and efficacy of bmmnc in patients with chronic renal failure

Conditions: Chronic Renal Failure

Summary: this study is single arm, single center trial to check the safety and efficacy of autologous bone marrow derived mono nuclear stem cell (bmmncs)for the patient with crf

chronic kidney failure, also called chronic kidney disease, describes the gradual loss of kidney function. kidney failure is a medical condition in which kidneys fail to filter metabolic wastes and toxins out of the body and a series of symptoms will be developed .it is common, frequently un recognised and often exists together with other conditions (for example, cardiovascular disease and diabetes). when advanced, it also carries a higher risk of mortality. the risk of developing ckd(chronic kidney diseases ) increases with increasing age, and some conditions that coexist with ckd become more severe as kidney dysfunction advances ckd can progress to established renal failure in a small but significant percentage of people. this classification divides ckd into five stages. stages 3-5 may be defined by glomerular filtration rate (gfr) alone, whereas stages 1 and 2 also require the presence of persistent proteinuria, albuminuria or haematuria, or structural abnormalities. stem cells have two important characteristics that distinguish them from other types of cells. first, they are unspecialized cells that renew themselves for long periods through cell division. the second is that under certain physiologic or experimental conditions, they can be induced to become cells with special function such as the beating cells of heart muscle or the insulin- producing cells of the pancreas as well as the neurons of brain.so our approach is to prove safety and efficacy of stem cell in crf

Eligibility criteria:
inclusion criteria: * age limit: 18 -65 * willingness to undergo bone marrow and umbilical cord derived mesenchymal stem cell transplantation. * to give an informed consent as well as sign the required informed consent form (icf) for the study. * willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol. exclusion criteria: * patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis a) gastrointestinal , cardiac, immunodeficiency (including hiv) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc. * women who are pregnant or lactating * chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders. * suffering from severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores. * positive test results for hiv and aids complex ,hcv (hepatitis c virus ), hbsag and syphilis * hemoglobin level below 7g % * estimated glomerular filtration rate (egfr) of \< 45ml/min

Keywords: crf stem cell ckd
laser acupuncture and pain management in preterm infants undergoing patent ductus arteriosus ligation

Conditions: Preterm Newborns

Summary: prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants.

management of pain in preterm infants is essential because it is exposed to repetitive movements painful and invasive miners such as surgical treatment of the ductus arteriosus which is accompanied by respiratory instability, increased consumption analgesics. acupuncture has shown its analgesic efficacy in numerous studies in children and adults. acupuncture (laser) is a simple, fast method without side effect used in children, but no study exists on the effect of acupuncture in the treatment of perioperative pain in addition to pharmacologic agents in preterm infants. hypothesis: acupuncture reduce pain and discomfort after surgery of the ductus arteriosus in preterm infants in addition to pharmacologic agents main objective: assessing the contribution of laser acupuncture on the pain management during endotracheal suctioning (ets) after surgery ductus arteriosus in preterm infants

Eligibility criteria:
inclusion criteria: * preterm infant born between 24 +0 and 32 +6 j ga * ductus arteriosus surgery scheduled in robert debré hospital * informed consent of the holders of the exercise of parental authority * child beneficiary of a social security scheme (excluding ame) exclusion criteria: * obvious underlying disease (genetic, metabolic)

Keywords: preterm newborns transfontanellar ultrafast doppler acupuncture perioperative pain surgery of the ductus arteriosus
a long-term follow-up study of pulmonary function changes using phase-resolved functional lung mri in patients with covid-19

Conditions: Pulmonary Function

Summary: so far, the number of covid-19 infections worldwide has exceeded 700 million. long-term damage to the lungs is a major sequela of covid infection. pulmonary function testing is an important means for the evaluation of lung damage. mri examinations with free breathing and no contrast agent can prevent patients from suffering from ionizing radiation damage caused by multiple ct examinations.


Eligibility criteria:
inclusion criteria: * older than 18 years; sign the informed consent; patients diagnosed with covid-19 by nucleic acid test and survived to be discharged; complete clinical data during hospitalization. exclusion criteria: * patients with bacterial pneumonia; patients with mri contraindications.
pilot study to investigate the impact of an app on the quality of life and symptoms of individuals affected by menopause

Conditions: Menopausal and Other Perimenopausal Disorders

Summary: the study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. a total of 224 participants were randomized into an intervention and a control group. findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. the study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.


Eligibility criteria:
inclusion criteria: * legal capacity * residency in germany * female sex * age ≥18 years * known and medically confirmed (peri-)menopausal disorder (n95.1, n95.3, n95.8, n95.9) * ownership of a smartphone and ability to use it * internet access for app usage and questionnaire completion * email address for registration * willingness to complete questionnaires online * motivation for regular app usage * sufficient proficiency in the german language * absence of exclusion criteria exclusion criteria: * changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks * changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks * previous or current access to the endo-app or other comparable digital health applications, or current active prescription * current participation in other clinical studies * failure to meet the inclusion criteria

Keywords: menopause digital therapeutics quality of life
antenatal chlamydia trachomatis and neisseria gonorrhoeae testing to prevent adverse neonatal consequences

Conditions: Chlamydia Trachomatis Infection; Neonatal Infection; Preterm Birth; Gonorrhea

Summary: to assess the effectiveness of chlamydia trachomatis (ct) and neisseria gonorrhoeae (ng) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).

in this study investigators are conducting a two-arm, cluster randomized trial to assess the effectiveness of chlamydia trachomatis (ct) and neisseria gonorrhoeae (ng) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs). investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive ct and ng testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. an additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. all participants will be tested for ct and ng at the first postnatal visit and those who test positive will be offered infant testing. investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal ct/ng infection. this study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.

Eligibility criteria:
inclusion criteria: * age ≥ 15 years, * currently pregnant, * attending first anc visit, * 27 weeks gestation or less * not currently experiencing ct/ng-related symptoms (determined by validated screening tool), * not treated for ct/ng in the past 30 days, * willingness to provide self-collected specimens for ct/ng testing (for the sti-testing group, this will take place at their first anc visit, at another visit in their third trimester, and at postnatal care. for the standard of care group, samples will only be collected at postnatal care), * willingness to return for a test of cure if ct/ng test is positive during antenatal care, * will reside in gaborone through the time of delivery and 1st postnatal visit, * willingness to have neonates tested for ct/ng at their first postnatal visit, * mentally competent to understand the informed consent. exclusion criteria: * not mentally competent to understand study procedures or give informed consent, * individuals \< 15 years, * men, * women who are not pregnant, * pregnant women not attending their first antenatal visit, * pregnant women at \>27 weeks gestation * pregnant women with current sti-related symptoms (will receive standard of care), * treated for an sti in the past 30 days.

Keywords: chlamydia trachomatis neisseria gonorrhoeae